Proteus Sustained Behavior Change Study

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Device-related and -unrelated adverse events [ Time Frame: Up to 4 months ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Proteus Sustained Behavior Change Study

Official Title ICMJE

Proteus Sustained Behavior Change Study

Brief Summary

The study will test whether the Proteus Sustained Behavior Change (SBC) System will help Type 2 diabetics feel more able to perform self-care activities, feel less distressed about diabetes, and reduce mean fasting blood glucose levels. The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest.

Hemoglobin A1c ≥7.5 and ≤11, obtained with the point-of-care HbA1c diagnostic device during the enrollment visit

Self-reported current use of metformin for Type 2 diabetes

Male or female ≥ 18

Outpatient

Self-reported capacity to perform "moderate" exercise, as specified by in the 2010 joint American College of Sports Medicine/American Diabetes Association guidelines

Designation of one caregiver to be involved in the study for its entire duration. A caregiver can be a relative, friend, or trained or untrained hired individual.

Self-reported mobile phone reception at home and/or at work

Willingness to adhere to study procedures, including troubleshooting of the Raisin System by a third-party if needed. The third party will be blinded to any personal subject identifiers.

Capacity to read and speak English proficiently, as judged by the investigator during the screening interview

Capacity to understand the instructions for the study, as judged by the investigator during the screening interview

Exclusion Criteria:

Self-reported treatment with metformin for less than 2 months at the time of screening

Self-reported adverse reaction to metformin (e.g., ongoing nausea, vomiting, bloating, diarrhea) or to other concomitant medications being administered at the time of screening

Self-reported use of injectable hypoglycemic agents, such as insulin, exenatide, liraglutide or pramlintide

Physical or medical condition that could prevent safe participation in moderate levels of physical activity, as surveyed by the Physical Activity Readiness Questionnaire (PAR-Q) and interpreted by the investigator

Inability to use a mobile phone (e.g., to find icons or to open and to read a SMS), or inability to operate the approved glucometer that will be provided for use in the study

Self-reported current (i.e., in the last 12 months) alcohol or drug abuse (including, but not limited, to use of marijuana)

Positive urine pregnancy test for women

Women of child bearing potential who are not using a medically accepted means of contraception. Accepted means of contraception include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy

Self-reported history of myocardial infarction within past 60 days

Self-reported history of cerebral vascular accident within past 60 days

Self-reported history of skin sensitivity to adhesive medical tape or metals

Self-reported history of acute or chronic dermatitis, excluding atopic dermatitis

Self-reported allergies that could preclude safe participation in the study

Current participation in another clinical study, or participation in a clinical study in the past 30 days during which an investigational device or drug was used

Any condition that, in the investigator's opinion, would preclude the subject's being able to meet all of the protocol requirements, or would compromise the subject's safety during participation in the study

Presence of cognitive impairment, as judged by the investigator during the screening interview

Inability to provide informed consent for any reason

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects